Preceding local therapy to STRIDE for pretreated patients

JRCT ID: jRCT1041230013

Registered date:22/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma
• Date of first enrollment: 15/05/2023
• Target sample size: 36
• Study type: Interventional
• Intervention(s): After local therapy (radiofrequency ablation, radiation therapy, hepatic arterial chemoembolization, or hepatic arterial chemotherapy), a single dose of 1500 mg durvalumab and 300 mg tremelimumab is administered, followed by durvalumab 1500mg every 4 weeks until tumor progression or unacceptable adverse event.

Outcome(s)

• Primary Outcome: Progression-free survival
• Secondary Outcome: Immunological response, Objective response rate, Tumor control rate, Overall survival, Subsequent therapy, Adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) clinically diagnosed as hepatocellular carcinoma
2) unsuitable for radical local therapy due to biloblar multiple nodules, ductal invasion, metastatic lesions, or other factors
3) previously treated by one or more systemic therapy
4) target lesion for paliative local therapy
5) preserved liver function
6) 18 years or older
7) ECOG Performance status <=2
8) preservation of major organ function
9) written informed consent

Exclude criteria

1) refractory ascites or pleural effusion
2) unsuitable for paliative local therapy
3) risky varices without prophylactic procedures
4) double cancer
5) metastases to central nervous system
6) severe complication
7) active infectious disease
8) pregnant or lactating women, or women of childbearing potential
9) mental disorder
10) patients who investigator regards as inappropriate for candidate

Related Information

• Primary Sponsor: Yamashita Tatsuya